Product Code: NJM


Products Classified as NJM

1339Bracket, Ceramic, OrthodonticOrthodontic Plastic Bracket.

Total Product Life Cycle (TPLC) Devices

1339Bracket, Ceramic, OrthodonticOrthodontic Plastic Bracket.

FDA Consensus Standards

Bracket, Ceramic, Orthodontic [37069]21 CFR §872.5470 🔎

Pre-market Notifications for NJM

K192202Clear21World Class Technology Corporation
K190608Mei Ceramic BracketOrthosun Co., Ltd.
K182672ROSA BracketGNI Co., LTD
K181271Signature Orthodontic SystemSignature Orthodontics
K180952Ceramic BracketMEM Dental Technology Co., Ltd
K1804043M Clarity Ultra Self-Ligating Brackets And Adhesive Coated Appliance System3M Health Care
K173440Carriere SLX 3D ClearOrtho Organizers, Inc.
K172845Symetri ClearOrmco Corporation
K132368VAPOR CERAMIC BRACKETORTHODONTIC DESIGN AND PRODUCTION, INC.
K122753EMPOWER CLEARAMERICAN ORTHODONTICS
K090933BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETSFORESTADENT BERNHARD FORSTER GMBH
K080749RADIANCEAMERICAN ORTHODONTICS
K902075INTRIGUE CERAMIC BRACKETLANCER ORTHODONTICS, INC.

Global Unique Device Identification Database

00652221287489Bracket, ceramic, orthodontic
00652221287465Bracket, ceramic, orthodontic
00652221287458Bracket, ceramic, orthodontic
00652221287434Bracket, ceramic, orthodontic
00652221287410Bracket, ceramic, orthodontic
00652221287403Bracket, ceramic, orthodontic
00652221287373Bracket, ceramic, orthodontic
00652221287366Bracket, ceramic, orthodontic
00652221287335Bracket, ceramic, orthodontic
00652221287328Bracket, ceramic, orthodontic
00652221287311Bracket, ceramic, orthodontic
00652221287304Bracket, ceramic, orthodontic
00652221287298Bracket, ceramic, orthodontic
00652221287274Bracket, ceramic, orthodontic
00652221287267Bracket, ceramic, orthodontic

Maude Adverse Events

3M UNITEK APC I3M UNITEK CORPORATION2018-06-22
3M UNITEK APC I3M UNITEK CORPORATION2018-06-22
3M UNITEK APC? 3M UNITEK CORPORAION2017-12-20
BRACES (DAMON CORMCO CORPORATION2017-11-01
APC(TM) FLASH-FREE CLARITY(TM) ADVANCED CERAMIC BRACKET3M UNITEK CORPORATION2016-10-20
APC II CLARITY ADVANCED CERAMIC BRACKET3M UNITEK CORPORATION2016-03-18
DAMON CLEARORMCO CORPORATION2013-11-18
DAMON CLEARORMCO CORPORATION2013-11-18
DAMON CLEARORMCO CORPORATION2013-11-18
DAMON CLEARORMCO CORPORATION2013-11-18
DAMON CLEARORMCO CORPORATION2013-11-18
APC FLASH FREE CLARITY SL CERAMIC BRACKET3M UNITEK2013-09-12
DAMON CLEARORMCO CORPORATION2012-05-01
DAMON CLEARORMCO CORPORATION2011-05-20
DAMON CLEARORMCO CORPORATION2010-11-20
PURE SAPPHIRE BRACKETSORTHO TECHNOLOGY, INC.2010-01-22
PURE SAPPHIRE BRACKETSORTHO TECHNOLOGY, INC.2009-07-13
MYSTIQUE ROTH OVATION MANDIBULAR ARCHDENTSPLY GAC INTERNATIONAL, INC.2004-07-02

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